The safety and performance of the GliaSite Radiation Therapy System (RTS) have been proven in a multi-center clinical study published in the August 2003 issue of the Journal of Neurosurgery. Twenty-one patients with recurrent malignant gliomas were treated with the GliaSite RTS at 6 centers. The study was cosponsored with the National Cancer Institute through the New Approaches to Brain Tumor Therapy (NABTT) Consortium.

Treatment centers:

Patient demographics:

• Number of patients: 21
• Diagnosis: Recurrent malignant glioma
• Average Age: 48.4 years (± 11.3)
• Karnofsky Performance Score: 80 (± 13.4)

Results

Median survival following reoperation for recurrence was 387 days.

The study confirmed the safety of the GliaSite RTS in delivering the prescribed doses of radiation. Patients experienced few side effects, and complications were consistent with those typically reported with surgical resection.

Additional Data:

In the clinical setting, results of 80 recurrent malignant glioma patients treated with GliaSite RTS have been evaluated. Nine treatment centers contributed data including:

• University of Arizona , Tucson , AZ
• St. Luke’s Medical Center , Milwaukee , WI
• Carolinas Medical Center , Charlotte , NC
• Medical University of South Carolina , Charleston , SC
• University of Pennsylvania , Philadelphia , PA
• Wake Forest University , Winston-Salem , NC
• University of Maryland , Baltimore , MD
• Medical College of Wisconsin , Milwaukee , WI
• University of Utah , Salt Lake City , UT

Patient Demographics:

• Number of Patients: 80
• Diagnosis: Recurrent malignant glioma (66 GBM and 14 AA/AO)
• Average Age: 51 years
• Karnofsky Performance Score (KPS): 80
• All patients had received previous surgery and external beam radiation with or without chemotherapy.

Results:

The overall median survival following treatment with GliaSite RTS was 267 days. The median survival for patients diagnosed with GBM was 252 days.

This data is consistent with the results found in the safety and performance study.